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St. Louis,
Missouri63110

Purpose:

This grant is to study patients that have received a kidney transplant AND an Islet Cell
transplant and to discover how the transplant is functioning. We will seek to have several
patients who have had a kidney transplant but do NOT have either type of diabetes. These
patients will serve as the "control group" since they will also be on immunosuppressive
medications but are not affected by abnormal blood sugars. This will allow investigators to
develop an understanding of how these immunosuppressive medications affect glucose
metabolism (blood sugar levels) and insulin utilization (how the body uses insulin).

Study summary:

If Islet Cell transplants are to become a reasonable treatment alternative for patients with
type 1 diabetes, there must be knowledge about how the islet cells function after transplant
{islet cells are responsible for making the insulin the body needs in order to control blood
sugar). This knowledge would allow for improvements in the islet cell transplant procedure
itself, as well as possible alterations of the immunosuppressive medications (drugs that
prevent rejection) that are prescribed. There are two basic kinds of diabetes, type 1
(formally known as Insulin Dependent or Juvenile diabetes) and type 2 (formally known as
Adult-Onset or Non-insulin dependent) diabetes. The patients in this study will be affected
by type 1 diabetes. After the transplant, it is hoped they will no longer need insulin
injections. It is possible patients may need to take pioglitazone and/or metformin,
however, this will be prescribed in Project 1, if needed.
The medications used for this study include: C-peptide. This is a synthetic product (not
from human or animal sources) that is man-made and identical to the C-peptide made by the
body. C-peptide is made at the same time as insulin, one molecule of insulin equals one
molecule C-peptide. By giving C-peptide that is synthetic, researchers can measure how the
C-peptide breaks down in the body, which could then be related to how insulin breaks down in
the body. Somatostatin will also be used during the same test as the C-peptide. While
receiving Somatostatin, the production of insulin by the patient will be stopped. This
medication will only be given for 4 hours and the blood sugar will be monitored during the
entire procedure. Insulin & Glucose will also be given by IV during certain tests to
regulate the blood sugar. Blood sugars will be maintained within a certain level and this
will be achieved through the administration of insulin and/or glucose. The patient's blood
sugar will be monitored at frequent intervals throughout the various procedures.

Criteria:

Type 1 diabetics that have received a kidney transplant as well as (under Project 1) Islet
Cell Transplant. A control group of 8 kidney transplant recipients who do not have
diabetes will also be sought. Age range for both groups is expected to fall in the 25-50
year/old range based upon statistical data, although those between the ages of 18 and 65
may also qualify.

NCT ID:

NCT00018122

Primary Contact:

N/A

Backup Contact:

N/A

Location Contact:

St. Louis, Missouri 63110United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: September 26, 2017

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